Scientist/Engineer – Small Molecule Technical Operations - Lilly Medicine Foundry

Lilly•Indianapolis, IN
•$67,500 - $151,800•Onsite

About The Position

The Scientist/Engineer – Technical Operations supports and may execute shift operations for Lilly’s Small Molecule area at the Lilly Medicine Foundry. The role provides hands-on floor support to operators, supports batch readiness and release, and supplies technical and operational oversight for routine manufacturing. It serves as an operations integrator with Process Engineering, Process Translation and Execution, and Product Research and Development to introduce processes, plan process changeovers, and support new product introduction. During facility pre-startup, the role contributes to operational readiness, technical process development, technology transfer, training, procedures, and workflows. Initial work includes equipment qualification and site acceptance testing, as well as developing standard operating procedures and operator training plans. After the project phase, the role provides technical ownership and oversight for operations, delivers floor training and process support, and leads incident investigations. It also contributes to process hazard reviews, development batch instructions, and pre-startup activities. The position may involve routine manufacturing activities and shift work as needed in future operations. It requires a safety-first, quality-always approach to production involving diverse unit operations and manufacturing skills. Domestic and international travel may be required to collaborate with, train at, and learn from sites that produce APIs. The initial work location is Lilly Technology Center in Indianapolis or Parkwood West in Carmel; the permanent location will be the new Lilly Medicines Foundry in Lebanon, Indiana. The role is on-site on a Monday–Friday schedule, with flexibility to support a 24/7 manufacturing environment, including nights and weekends as needed. Travel is approximately 5%.

Requirements

  • Bachelor’s or associate degree in science, engineering, or a technical field; alternatively, a high school diploma/GED with 5 or more years of directly applicable pharmaceutical manufacturing experience.
  • For the high-school/GED pathway, directly applicable experience must include pharmaceutical operations in Small Molecule, Biologics, or Mixed Modalities, including operations, safety and quality incident investigations, authoring procedures or instructions, and process hazard reviews.
  • Must be authorized to work in the United States on a full-time basis; Lilly will not sponsor work authorization or visas for this role.
  • Ability to work on-site on a Monday–Friday schedule and flexibly support manufacturing operations during nights and weekends as needed.
  • Ability to travel domestically and internationally as needed; stated travel is approximately 5%.

Nice To Haves

  • Experience in Pharmaceutical Product Research and Development.
  • Experience providing technical or coordination support for cleaning, changeover, or maintenance activities in a GMP production environment.
  • Formal project management training.
  • Demonstrated leadership and influencing experience.
  • Previous experience in facility or area startup environments.
  • Strong understanding of FDA guidelines and cGMP requirements.
  • Strong organizational skills and ability to handle and prioritize multiple requests.
  • Knowledge of lean manufacturing principles.
  • Flexibility in troubleshooting and triaging challenges.
  • Ability to understand technical nomenclature and language and work with mathematical formulas.
  • Effective electronic, written, and verbal communication skills.

Responsibilities

  • Provide on-floor shift support to operations staff for technical, training, and process needs, and at times execute production activities.
  • Evaluate processes, protocols, and deviations in real time and provide assessments to cross-functional process teams.
  • Use independent judgment to execute equipment commissioning and qualification testing under the guidance of C&Q.
  • Conduct and document production in accordance with digital manufacturing batch records and affiliated SOPs.
  • Follow applicable procedures, cGLP, cGMP, company policies, and quality and regulatory requirements.
  • Document and assess improvement opportunities identified by operators.
  • Work with area maintenance to schedule corrective-maintenance work orders.
  • Lead safety and quality investigations and author investigation reports.
  • Collaborate across functions to enable Foundry technology transfers.
  • Serve as a resource for operational improvement projects and other initiatives.
  • Partner with functional groups to plan process campaigns and changeover execution, including cleandown, piping, maintenance, and equipment setup; coordinate and oversee execution against timelines.
  • Work with Process Engineering, Process Translation and Execution, Product Research and Development, HSE, and Quality Assurance to ensure processes are transferred and executed successfully.
  • Apply Health, Safety & Environmental requirements and Health & Safety/Process Safety standards, representing operations in Process Hazard Review meetings and other HSE venues.
  • Promote continuous improvement of area changeover workflows.
  • Collaborate effectively in a fast-paced team environment.

Benefits

  • Company bonus, depending in part on company and individual performance.
  • Eligibility to participate in a company-sponsored 401(k).
  • Pension.
  • Vacation benefits.
  • Eligibility for medical, dental, vision, and prescription drug benefits.
  • Flexible benefits, including healthcare and/or dependent day care flexible spending accounts.
  • Life insurance and death benefits.
  • Certain time-off and leave-of-absence benefits.
  • Well-being benefits, including an employee assistance program, fitness benefits, and employee clubs and activities.
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